The Recall Desk
CriticalFDA (Drugs)·D-0762-2019·Announced 2019-03-20

FDA Recalls King Bio TremorPlex Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx TremorPlex U.S. bottles due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this recall as Class I, which per the rubric mandates a severity score of 5 (Critical) as it indicates a reasonable probability of serious adverse health consequences or death.

Plain-English summary

King Bio Inc. is voluntarily recalling 289 bottles of Dr. King's SafeCare Rx TremorPlex U.S., 2 fl. oz. (59 mL), due to microbial contamination. The FDA has classified this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.

The affected product is identified by NDC 57955-0033-2 and UPC 357955003328. Specific lots involved include 022516C (Exp. 02/19), 072916F (Exp. 07/19), and 030117C (Exp. 03/20). The product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers who have purchased this product should stop using it immediately and contact King Bio Inc. for further instructions or a refund. The recall is being conducted to prevent potential health risks associated with the microbial contamination.

The recalled product

Product
Dr. King's SafeCare Rx TremorPlex U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955003328, NDC 57955-0033-2
Manufacturer
King Bio Inc.
Category
Drug — Supplement
Hazard
Affected units
289

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lots: 022516C Exp. 02/19
  • 072916F Exp. 07/19
  • 030117C Exp. 03/20

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 465 recalled by King Bio Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 465 products in this recall →

Related recalls

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Same hazard · microbial contamination

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